Shantha West Inc has found monoclonal antibodies that have great use for cancer treatment. It has two monoclonal antibodies, TB-94 and RN-2. TB-94 is a promising antibody in the treatment of lung and colon cancers whereas RM-2 can be suitable for lung and skin cancers.
Dr Sonjoy Mukerjee, head, monoclonal antibodies and viral vaccines, Shantha Biotechnics, told Pharmabiz, the company already has patents for its antibody and antigen for its monoclonal antibody TB-94. It also has combined patents for both the antibodies, TB-94 and RM-2, as a multi-map therapy for lung cancer.
Dr Mukerjee said, "Cancer itself is a heterogeneous disease. The antibodies generate immune responses that are highly specific against tumour antigen."
Shantha West, US is a joint venture with East West Laboratories, US involved in the development of novel therapeutic monoclonal antibodies for the treatment of different types of cancer.
Pre-clinical study has been completed individually and for the combined antibodies for treatment of lung cancer. Growth tumours have been engrafted in mice and studied. Based on histology studies, toxicology studies are designed. The antibodies have been able to shrink the tumour in mice. Antibody dependant cell mediated cytotoxity has been studied along with mode of action in tissue culture and mice.
Based on the histology, animal toxicology studies are on the anvil. The studies will be conducted on small and large animals. Progress in the animal toxicology studies can be seen by January, 2006. The antibodies will be produced through a contract manufacturer in the US, Mukerjee informed.
The animal toxicology studies can be carried out for six months, and the antibodies will reach phase I stage. Phase I will be carried out both in India and the US. The company will submit IND to FDA. Shantha Biotechnics' Hyderabad facility will be used to produce antibodies for meeting the needs of phase I trial.
Mukerjee added that toxicology studies of human trails phase IIa and IIb will be initiated later. Most of the antibodies have been approved by the FDA after phase II trials. The criteria for getting marketing nod from FDA have been that the antibodies should be able to prolong the life for another 6-8 months at the minimum, through treatment. Shantha West expected BLA to be filed by 2009 and the studies will be completed by 2010.
Shantha West has isolated lymph nodes of patients having high concentration of B cells, which secrete lymphocytes. It has further developed a cell line that contains the antibodies.
Phase IIb trials will be also carried out in India and the US. Shantha West will ensure that state-of the-art treatment is available to patients in India, for lung cancer. There is a gap in treatment of lung cancer, and Shantha West is keen to fill this gap, according to Mukerjee.
Gene cloning, sequencing of antibodies, antigen identification has been conducted in India at Shantha Biotechnics.
With adherence to GMP and international reputation, Shantha Biotech is capable of producing antibodies in kg quantities at low cost. Shantha Biotechnics will support Shantha West in the areas of intellectual inputs, manufacturing support by taking part clinical trials. A 30-member strong team at Shantha Biotech in India is contributing towards the efforts by enabling reduction in project time and cost.